API List 3 >>
Piroxicam Betacyclodextrine cannot be expected to substitute for
corticosteroids or to treat corticosteroid insufficiency. Abrupt
discontinuation of corticosteroids may lead to disease exacerbation.
Patients on prolonged corticosteroid therapy should have their therapy
tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Piroxicam Betacyclodextrine in reducing
fever and inflammation may diminish the utility of these diagnostic signs in
detecting complications of presumed noninfectious, painful conditions.
Piroxicam Betacyclodextrine, like other NSAIDs, may cause CV side effects,
such as MI or stroke, which may result in hospitalization and even death.
Although serious CV events can occur without warning symptoms, patients
should be alert for the signs and symptoms of chest pain, shortness of
breath, weakness, slurring of speech, and should ask for medical advice when
observing any indicative sign or symptoms. Patients should be apprised of
the importance of this follow-up (see WARNINGS, Cardiovascular Effects).
Piroxicam Betacyclodextrine, like other NSAIDs, can cause GI discomfort and,
rarely, serious GI side effects, such as ulcers and bleeding, which may
result in hospitalization and even death. Although serious GI tract
ulcerations and bleeding can occur without warning symptoms, patients should
be alert for the signs and symptoms of ulcerations and bleeding, and should
ask for medical advice when observing any indicative sign or symptoms
including epigastric pain, dyspepsia, melena, and hematemesis. Patients
should be apprised of the importance of this follow-up
Patients should promptly report signs or symptoms of unexplained weight
gain, or edema to their physicians.
Patients should be informed of the warning signs and symptoms of
hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right
upper quadrant tenderness and "flu-like" symptoms). If these occur, patients
should be instructed to stop therapy and seek immediate medical therapy.
Patients should be informed of the signs of an anaphylactoid reaction (e.g.
difficulty breathing, swelling of the face or throat).
Piroxicam is excreted into human milk. The presence in breast milk has been
determined during initial and long-term conditions (52 days). Piroxicam
appeared in breast milk at about 1% to 3% of the maternal concentration. No
accumulation of piroxicam occurred in milk relative to that in plasma during
treatment. Piroxicam Betacyclodextrine is not recommended for use in nursing
Safety and effectiveness in pediatric patients have not been established.